Tobacco Deeming Rules Just a First Step

As an example, Zeller said a person with a pack-a-day cigarette habit who switched totally to e-cigarettes may lessen his or her health risk. But a smoker who uses e-cigarettes as a way to avoid kicking the habit, may not be achieving a higher level of health.

The other aspect of the rule that the two officials discussed in more detail was its initial limitations. Calling it a “foundation” and a “walk before you run” step, they said the rule was meant to initially establish jurisdiction over these products.

Currently, there is no regulation over these products—even to the extent of age restriction. Also, news accounts have said some of the devices have exploded while charging, according to Zeller, who called the category “the wild, wild West.”

Establishing jurisdiction would compel manufacturers to register new products, provide ingredient information and insight on how they made their products. It would broaden the research process already begun by the FDA and then move to involve manufacturers. Thus, additional issues like regulation over flavors or TV and online advertising, could then be taken on as separate matters, involving their own discovery timeframes and individual rulings.

The current proposal, once finalized, would require manufacturers to submit an application for FDA approval within a two-year timeframe. By doing so, it would allow for manufacturers to continue to produce, advertise and sell product while awaiting the FDA’s decision. Beyond that timeframe, all new products would have to await approval before going to market.

Zeller expressed confidence in the FDA’s ability to move on new applications, saying it has cleared any existing backlog in this category and is ready to move on new cases.

Sebelius thanked her team and said the move was one of many—including drug-store chain CVS deciding to stop selling tobacco, the state of Georgia banning smoking on college campuses and the FDA’s own media campaign to convince teens to stop smoking—as major efforts “to make the next generation of Americans tobacco free.”

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